IQVIA MEDTECH RECALL AND FIELD ACTION PROGRAM

Be Recall Ready

Recalls happen to even the most diligent companies and the impact on business is often underestimated. As the regulatory landscape continues to evolve, MedTech companies need a customized plan that can be implemented with speed and accuracy on a global scale.

IQVIA MedTech offers a global, flexible outsourced solution that supports in the management and execution of your recalls and field actions. 

A flexible, outsourced, global solution

What makes IQVIA MedTech different?

Is your business able to respond proactively to recalls? Are your teams prepared to respond with speed and agility?

IQVIA MedTech’s customized approach executes recalls and field actions quickly and accurately without overburdening your teams. With a dedicated, 3,500-strong global recall team, our service solution builds global execution teams for each step of the recall, incorporating an automated recall platform to track every activity to support your recall planning and enable you to respond with agility.

Based on real events: 3 Recalls at the same time

86%

IQVIA MedTech average response rate for recalls.

3,500

Size of the IQVIA MedTech dedicated recall team across our global field-based and support center teams ready for rapid deployment.

96%

IQVIA MedTech’s recall customer retention rate.

Whitepaper: Recall Readiness for MedTech Companies

in 2022, there were almost 12,000 recalls affecting nearly 62 million products worldwide. Is the industry Recall Ready?

Brochure: IQVIA MedTech Recall and Field Action Program

Download details about IQVIA MedTech’s flexible, outsourced, global Recall and Field Action Program.

Case Study: Global Recall Success

A global ophthalmology manufacturer faced a critical recall of faulty laser fibers, requiring removal and destruction of affected products across 44 countries. Due to regulatory pressures, the company needed a structured, efficient, and compliant recall process.

The manufacturer’s faulty laser fibers posed potential risks to patients, prompting a Class 2 recall as designated by the FDA. This meant the issue, while not immediately life-threatening, still required urgent attention to prevent long-term harm.


The recall needed to be executed at both consignee and distributor levels, ensuring all affected devices were accounted for and removed from circulation. Given the global scale of the recall, the company required a structured program to ensure regulatory compliance, proper notification of consignees, tracking of returned products, and certified destruction.

Challenge

Logistics Hurdle

Despite the urgency of the recall, the manufacturer lacked the necessary logistics, communication infrastructure, and regulatory expertise to efficiently handle product removal across multiple regions.

  1. Regulatory Compliance & Deadlines: The recall was under strict timelines imposed by regulatory authorities, and the manufacturer was at risk of non-compliance.

  2. Global Scale & Language Barriers: The recall spanned 44 countries, requiring communication with 247 consignees in 9 different languages. The client lacked the internal resources to manage multi-language outreach.

  3. Logistics Complexity: The recall involved tracking and coordinating the removal of 3,725 devices—a challenge due to the dispersed nature of consignees and distribution centers.

  4. Low Initial Response Rates: Many consignees were unresponsive, necessitating multiple notification attempts to ensure compliance with regulatory standards.
Solution

Strategic Recall

IQVIA MedTech provided a customized Global Recall & Field Action Program, implementing structured communication, tracking, and logistics support to ensure a successful and timely recall.

  1. Custom Recall Management Strategy: Developed a tailored recall solution with clear objectives and a structured timeline aligned with regulatory requirements.

  2. Multichannel Communication & Outreach: Built a custom web portal for digital responses and deployed a scalable call center to conduct outbound calls, ensuring every consignee was notified. A minimum of three due diligence attempts per consignee was enforced.

  3. Regulatory Compliance & Reporting: Ensured 100% notification efforts per regulatory guidelines and provided weekly progress reports to track responses and expected product returns.

  4. Global Logistics Support: Coordinated the collection and destruction of defective devices in native languages, ensuring smooth execution across different regions.

  5. Serial Number-Level Tracking: Implemented detailed tracking and reconciliation of returned devices, ensuring accurate serial-number-level documentation for compliance verification.
Results

Recall Success

The structured recall program led to a 96% response rate, full regulatory compliance, and on-time completion of the recall across all 44 countries.

  • 96% overall response rate achieved, surpassing industry benchmarks.

  • 79% response rate via digital channels, demonstrating the effectiveness of the online web portal.

  • 1,265 outbound calls conducted to engage non-responding consignees.

  • All product returns completed on time, ensuring regulatory compliance and avoiding penalties.

  • Certified destruction of affected products was successfully documented.

  • Project completed within 12 weeks, on schedule and within budget.
Be Recall Ready: Contact us
Enquire about the IQVIA MedTech Recall and Field Action Program today

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